On Monday, the Food and Drug Administration (FDA) fully approved Moderna’s COVID-19 vaccine based on follow-up data showing “high efficacy and favorable safety approximately six months after the second dose.”

“The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” Acting FDA Commissioner Janet Woodcock said in a statement.

“While hundreds of millions of doses of Moderna COVID-19 Vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated.”

The FDA granted full approval to Pfizer’s COVID-19 vaccine in August.

“Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization and death,” Moderna CEO Stéphane Bancel said in a statement.

“The totality of real-world data and the full [approval] for Spikevax in the United States reaffirms the importance of vaccination against this virus. This is a momentous milestone in Moderna’s history as it is our first product to achieve licensure in the U.S.” 

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FDA fully approves Moderna COVID-19 vaccine